Recall Z-0580-2009 · JIX Calibrator, Multi-Analyte Mixture

Abbott Laboratories Inc.

ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. The device is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The product is used to calibrate assays used to determine bilirubin concentrations in neonate and adult patient samples.

Date	Jan 12, 2009 (initiated Sep 12, 2008)
Status	Terminated
Reason	The field action was initiated after an investigation for the Total Bilirubin reagents (List Number 8G62 and List Number 6L45) determined that the matrix of the secondary standard used in the value assignment of the calibrator is sensitive to the Diazo method. The matrix of this secondary standard caused a positive bias. Because of these findings, a new Total Bilirubin calibrator value assignm
Root cause	Component design/selection
Action	On September 12, 2008, a Product Correction letter with an attached Customer reply form was mailed via US Postal Service to all affected customers that have received the affected lots. The letter instructed customers to take the following actions: 1. Identify the lot number(s) of Clinical Chemistry Bilirubin Calibrator currently used in your laboratory; 2. Replace the calibrator value sheet with the appropriate attachment provided with this letter. Discard the previous calibrator value sheet; 3. Configure the revised Total Bilirubin calibrator values provided in the Attachments, for the appr
Quantity	7,101 units worldwide (2,267 units in US).
Distribution	Worldwide Distribution including United States, Mexico, Columbia, Uruguay, Puerto Rico, Canada, Hong Kong, New Zealand, Bahamas, Guatemala, Argentina, Germany, Thailand, Trinidad/Tobago, Venezuela, Chile, Brazil, El Salvador, Singapore, Australia, Curacao and Cayman Island.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.